Agency classClass IIOur severity:High FDA (Drugs)·D-0963-2023·Announced 2023-08-09

IV Phenylephrine bags recalled for lack of sterility assurance

Central Admixture Pharmacy Services recalled 9,432 IV bags containing phenylephrine due to lack of assurance of sterility and insufficient validation data for decontamination cycles. The product was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II sterile injectable medication with potential microbial contamination risk. No reported illnesses or injuries. Classified as High per the rubric's criterion for risk-of-harm products without reported injury.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 9,432 bags of phenylephrine 40 mg/250 ml IV solution (NDC: 72196-6092-1) distributed nationwide in the United States.

The recall was initiated due to lack of assurance of sterility. The manufacturer was unable to provide sufficient validation data for the decontamination cycles used in production of these IV bags.

This product may have been distributed to hospitals and healthcare facilities across the United States. Healthcare providers who received this product should stop using it immediately.

For instructions on return or disposal, contact Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043.

The recalled product

Product: PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable / IV Solutions
Hazard: sterility-failure
contamination-risk
Affected units: 9,432

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot: 36-240803
Exp. 7/17/2023
36-241149
Exp. 7/19/2023
36-241912
Exp. 7/23/2023
36-243527
36-243529
Exp. 7/30/2023
36-244889
36-244890
36-244891
Exp. 8/1/2023
36-246709
36-246710
36-246711
36-246712
Exp. 8/6/2023
36-247014
Exp. 8/7/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 95 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 95 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Severe
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High
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FDA (Drugs) · 2023-10-11
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Same hazard · sterility failure